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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE SPA SMR ANATOMIC RESECTION JIG; KWT, HSD
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LIMACORPORATE SPA SMR ANATOMIC RESECTION JIG; KWT, HSD Back to Search Results
Model Number 9013.50.304
Device Problems Fitting Problem (2183); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2016
Event Type  malfunction  
Manufacturer Narrative
The check of the dhr of the lot # involved did not show any anomaly on the 75 smr resection jigs (lot 2014aa134) manufactured with the lot # involved.We will submit a final report once our investigation is concluded.
 
Event Description
Intra-operative issue occurred on (b)(6) 2016 involving a smr anatomic resection jig (model #9013.50.304): while the surgeon was drilling the pins to fix the resection jig to the humeral head, one of them didn't fit into the resection guide and jammed.The surgeon then swapped to another pin.No reported consequences for the patient.Event occurred in the (b)(6).
 
Manufacturer Narrative
The check of the dhr of the lot # involved did not show any anomaly on the 75 smr resection jigs manufactured with the lot# 2014aa134, and also on the 601 pins manufactured with the lot# 2014aa103.We received the jig and 2 pins with lot# 2014aa103.They underwent a dimensional check which gave the following results: the diameter of the two pins (male diameter) are both compliant to specifications, even if very near to the maximum allowed; of the 7 total holes (female diameter) of the resection jig, 2 are slightly under-dimensioned (maximum deviation: -0.07mm).In addition, one of the returned pins is very damaged on the external surface, and this prevents a proper sliding of this damaged pin through all the holes of the resection jig (also the holes of the jig with diameter compliant to specification).Summarizing: the root cause of this intra-op issue is the strong damage on the external surface of one of 2 pins (probably due to its repeated and maybe incorrect use).The slight under-dimensioning of 2 holes of the resection jig contributed to the issue reported.This is confirmed by the fact that the non-damaged pin can pass through 6 holes of the jig.This pin cannot pass through the 7th hole only (the one which is more under-dimensioned, -0.07mm).No corrective action for this specific case.In may 2016, the technical drawing of the smr reverse resection jig was modified in order to slightly increase the holes diameter and reduce the risk of intra-op seizure of the pin into the holes.Pms data: limacorporate is aware of a total of 6 similar events with smr anatomic resection jigs model # 9013.50.304.For the cases where we received and could analyze the devices involved, the cause of the seizure between jig and pin was identified to be the damage on the external surface of the pin (male taper), maybe due to its improper use, combined with the dimensions of the pin diameter very near to the maximum allowed or slightly exceeding the maximum allowed (after damaging).In this specific case, also the under-dimensioning of one hole of the jig may have contributed to the issue.A total of about (b)(4) implants have been performed ww with these resection jigs since july 2014, giving an occurrence rate of (b)(4).The anatomic resection jigs involved in all the 6 cases reported were manufactured before the technical improvement on the holes diameter.No complaints have been reported on the improved anatomic resection jigs.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of this issue and assess the effectiveness of the corrective action performed.
 
Event Description
Intra-operative issue occurred on (b)(6) 2016 involving a smr anatomic resection jig (model #9013.50.304): while the surgeon was drilling the pins to fix the resection jig to the humeral head, one of them didn't fit into the resection guide and jammed.The surgeon then swapped to another pin.No reported consequences for the patient.Event occurred in australia.
 
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Brand Name
SMR ANATOMIC RESECTION JIG
Type of Device
KWT, HSD
Manufacturer (Section D)
LIMACORPORATE SPA
via nazionale, 52
villanova di san daniele, 33038
IT  33038
MDR Report Key6749924
MDR Text Key81506241
Report Number3008021110-2016-00122
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K100858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9013.50.304
Device Lot Number2014AA134
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2016
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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